Drug to treat anemia in dialysis patients

WASHINGTON, March 29 (UPI) -- The U.S. Food and Drug Administration has approved a drug that treats anemia in adult dialysis patients who have chronic kidney disease.

Omontys, or peginesatide, is a new erythropoiesis-stimulating agent that aids in the formation of red blood cells by stimulating bone marrow to produce more red blood cells -- usually measured as hemoglobin levels -- to reduce the need for transfusions in patients with chronic kidney disease, the FDA said.

"Omontys represents the first new FDA-approved and marketed erythropoiesis-stimulating agent for this condition since 2001," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "This new drug offers patients and healthcare providers the convenience of receiving therapy just once per month instead of more frequent injections."

The trials randomly selected a 1,608 patients, with hemoglobin levels initially stabilized, to receive either Omontys once monthly or to continue their current erythropoiesis-stimulating agent (epoetin) treatment. Omontys, marketed by Affymax Inc. of Palo Alto, Calif., was as safe and effective as epoetin in maintaining hemoglobin levels within the studies' pre-specified range of 10 to 12 grams per deciliter, Pazdur said.

Omontys should not be used in patients with chronic kidney disease, who are not receiving dialysis or in patients with cancer-related anemia, the FDA said.

"It also should not be used as a substitute for red blood cell transfusions in patients who require immediate correction of anemia," the FDA statement said.

United Press International is a leading provider of news, photos and information to millions of readers around the globe via UPI.com and its licensing services.

With a history of reliable reporting dating back to 1907, today's UPI is a credible source for the most important stories of the day, continually updated - a one-stop site for U.S. and world news, as well as entertainment, trends, science, health and stunning photography. UPI also provides insightful reports on key topics of geopolitical importance, including energy and security.

A Spanish version of the site reaches millions of readers in Latin America and beyond.

UPI was founded in 1907 by E.W. Scripps as the United Press (UP). It became known as UPI after a merger with the International News Service in 1958, which was founded in 1909 by William Randolph Hearst. Today, UPI is owned by News World Communications.